Kornimate/medical-research-clean huggingface dataset:
a drug interaction study of slm0807 and hkb0701 in healthy subjects

Conditions: Diabetes Mellitus

Summary: the aim of this study is to assess whether hkb0701 alters pharmacokinetics of slm0807.


Eligibility criteria:
inclusion criteria: * healthy volunteers who are in age range of 20-50years and the weight range is not exceed ±20% of ideal weight. ideal weight = \[height -100\]\*0.9 * subjects with no history of any significant chronic disease * judged to be in good health on the basis of their vital sign, ecg, physical exam and routine laboratory data * available for the entire study period * willing to adhere to protocol requirements and sign a informed consent form. exclusion criteria: * subjects who have taken any drugs to induce or inhibit hepatic enzyme activity within 30days prior to drug administration * subjects who have symptom of an acute illness within 4 weeks prior to drug administration * subjects with a history of clinically significant allergies including drug allergies * subjects whose clinical laboratory test values are outside the accepted normal range(especially,ast or alt \>1.25 times to normal range or total bilirubin \> 1.5times to normal range) * subjects with a history of drug, caffeine or alcohol abuse (caffeine drink \>5cups /day, alcohol \>30g/day) * heavy smoker ( \>10cigarettes/day) * subjects who have had a diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) * subjects who have donated plasma within 60days prior to drug administration * subjects who have participated in a clinical study within 90days prior to drug administration * subjects who have received any drugs that might confound the results of the trial in the opinion of principal investigator (cimetidine within 7days prior to drug administration) * female subjects who are pregnant, breastfeeding or not using medically acceptable birth control
oricar-017 chimeric antigen receptor (car) modified t cells for the treatment of r/rmm

Conditions: Relapsed and/or Refractory Multiple Myeloma

Summary: an open label, dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of oricar-017 in r/rmm

this is a phase i and phase ii, open-label, multi-center study to assess the safety, pharmacokinetics, and efficacy of gprc5d directed chimeric antigen receptor modified t cells injection (oricar-017) in n patients with relapsed and/or refractory multiplemyeloma (r/rmm).

Eligibility criteria:
main inclusion criteria: * diagnosis of r/rmm according to the imwg criteria; * expected survival period is \>12 weeks; * eastern cooperative oncology group (ecog) performance status 0 or 1 or 2 at the time of icf signature; * the expression of gprc5d in bone marrow plasma cells membrane is more than 20% by flow cytometry and/or immunohistochemistry, multiple myeloma with measurable lesions, and at least one of the following criteria must be met: 1. serum m protein \>5 g/l; 2. urine m protein level \>200 mg/24 hour; 3. serum free light chain (sflc) \>100 mg/l and k/λ flc ratio is abnormal; 4. primitive immature or monoclonal plasma cells \>5% by bone marrow cytology or flow cytometry. * subjects who had received at least 3 prior lines of therapy including (but not limited to) immunomodulatory drugs (imids), proteasome inhibitors, anti-cd38 monoclonal antibodies, etc., but have failed treatment, including those who have experienced relapse (within 12 months), refractory or intolerant to the last line treatment regimen. main exclusion criteria: * smoldering myeloma (asymptomatic) * multiple myeloma with only extramedullary lesions; * plasma cell leukemia; * concurrent amyloidosis; * central nervous system metastasis, leptomeningeal disease or metastatic central compression; * hbsag or hbcab is positive, and the quantitative detection of hepatitis b virus (hbv) dna in peripheral blood is more than 100 copies/l; hepatitis c virus (hcv) antibody and hcv rna in peripheral blood is positive; human immunodeficiency virus (hiv) antibody positive; syphilis antibody is positive at screening; cytomegalovirus dna test is positive; * had hypersensitivity or intolerance to any drug/excipient (including conditioning chemotherapy) used in this study; * previously received treatment targeting gprc5d, including but not limited to antibodies, adc, or car-t; * subjects who received autologous hematopoietic stem cell transplantation (asct) within 8 weeks of screening visit or who plan to undergo asct during the study; * any uncontrolled active infection within 4 weeks prior to icf signing or leukapheresis requires parenteral antibiotic, antiviral, or antifungal treatment * major surgery within 28 days prior to screening visit with the exception of a biopsy and an insertion of a central venous catheter or during the study; * subjects who received allogeneic stem cell therapy; * subjects complications or other conditions evaluated by investigators may affect compliance with the protocol or make them unsuitable to participate in this study; * pregnant or breastfeeding.
cognitive decline following deep brain stimulation: a dbs-fmri study

Conditions: Deep Brain Stimulation; Parkinson Disease

Summary: the objective of this research study is to understand how deep brain stimulation (dbs) targeting the subthalamic nucleus (stn) affects cognitive networks in the brain, potentially leading to cognitive decline in patients with parkinson's disease (pd). a total of 55 participants with pd who have undergone dbs surgery will be recruited from musc's clinical dbs program. participants will attend two post-dbs visits: a 3-hour visit for consent, demographic, and cognitive assessments, and a 3-hour dbs-mri visit to evaluate brain network connectivity with stimulation on and off. these findings will help improve patient selection for surgery and optimize the selection of stimulation targets that minimize undesirable cognitive side effects.

deep brain stimulation (dbs) targeting the subthalamic nucleus (stn) is a well-established surgical intervention to treat parkinson's disease (pd) patients with disabling motor fluctuations and dyskinesias. although this therapy is effective for motor complications, a subset of patients will go on to experience cognitive decline, which can overshadow improvements in the quality of life provided by stn-dbs. this accelerated decline in cognition occurs in patients despite rigorous evaluation of their neuropsychological status prior to surgery. while the factors contributing to cognitive decline following dbs remain unclear, there is evidence this may be the result of 1) limited cognitive reserve prior to dbs surgery, 2) stimulation that interferes with cognitive networks, and/or 3) a microlesion effect due to placement of the lead. this research seeks to identify how dbs-induced changes in neural connectivity contribute to cognitive decline and how brain microstructure influences these changes. understanding how these factors has the potential to improve patient selection for surgery and optimize the selection of stimulation targets that minimize undesirable cognitive side effects.

Eligibility criteria:
inclusion criteria: * subjects above 18 years of age * individuals with a pd diagnosis as defined by the uk brain bank diagnostic criteria for parkinson's disease (58) which have undergone a neurological and neuropsychological evaluation at muscs movement disorder center, and were selected to undergo 3t compatible unilateral or bilateral stn- dbs implants exclusion criteria: * uncorrected visual or hearing impairments, as indicated by self-report * individuals who are pregnant or expect to become pregnant during the course of the study * individuals that have a history of neurological disease (other than pd) including previous stroke, major head trauma, and epilepsy or seizures. * individuals with claustrophobia, or the inability to lie supine position in the mri scanner * copd with oxygen dependence * non-mri compatible metal implants (surgical clips or staples, cardiac pacemakers etc.)

Keywords: brain parkinsons deep brain stimulation cognitive
cognitive behavioral therapy by humor based psychoeducation

Conditions: Depression

Summary: this study aims to reveal the effectiveness of based cognitive behavioral therapy by humor based psychoeducation on sense of humour, self-esteem and depressıon level patient in diagnosed with deppression .

aim: this study aims to reveal the effectiveness of based cognitive behavioral therapy by humor based psychoeducation on sense of humour, self esteem and depression level patient in diagnosed with depression . method: this study will be conducted as a randomized controlled experimental study by the researcher, who is a specialist psychiatric nurse, to the elderly patient in diagnosed with depression staying in the mardin traning and research hospital and kızıltepe state hospital. in the study, "power analysis" was performed and a total of 44 individuals, including 22 intervention people and 22 control group, were considered suitable for the sample size. it was decided to have 30 people in the groups, considering the high power of the test and the loses in the study. accordingly, 30 people were determined as the intervention group and 30 people as the control group. in this study, personal ınformation form, coping humor scale, rosenberg self-esteem scale, beck depression scale, multidimensional sense of humor scale. findings: aims to reveal the effectiveness of based cognitive behavioral therapy by humor based psychoeducation on sense of humour, self esteem and depression levels patient in diagnosed with depression .

Eligibility criteria:
inclusion criteria: * volunteering to participate in the study * not having any obstacle to communication * being between the ages of 18 and 65 * being monitored on an outpatient basis with a diagnosis of depression according to the diagnostic and statistical manual of mental disorders criteria * being literate * not having undergone such training in the last 6 months exclusion criteria: * serious factors that may prevent you from answering the survey * presence of physical and cognitive disability * refusing to participate in the study after being informed * having a comorbid psychiatric diagnosis * a patient diagnosed with depression with psychotic features * having received any psychotherapy in the last 6 months

Keywords: cognitive behavioral therapy depression humor
evaluation of the public health interest of kaletra: impact on resistance to antiretrovirals (arvs)

Conditions: HIV Infection

Summary: the purpose of this study is to evaluate, in patients in at least the second protease inhibitor (pi) line, the virological failures under kaletra® and their consequences on protease and reverse transcriptase genotypes

the purpose of this study is to evaluate, in patients in at least the second pi line, the virological failures under kaletra® and their consequences on protease and reverse transcriptase genotypes: * characterisation of the changes in the resistance genotype in protease and reverse transcriptase, * description of the nature and frequency of selected mutations under kaletra®, * description of the predictive factors for mutations and of the impact they could have on other pis used as maintenance treatment (analysis based on available algorithms). eole is a prospective, multicentre observation study offered to french virology laboratories and involving clinical teams . it is a transversal study with retrospective data collection for patients meeting the study criteria (virological failure under kaletra® after at least first line pi treatment). the study comprises two enrolment periods, separated by an interval of one year, over a period ranging from 2007 to 2011. during this period, virological failures under kaletra® are identified. for each period, the virologists collect data only from the moment when virological failure under kaletra® is identified. the first wave of data collection is now completed and occurred from december 5, 2007 to july 03, 2009. it is not planned to collect follow-up data in connection with alternative treatment with other antiretrovirals after failure under kaletra®.

Eligibility criteria:
inclusion criteria: * patient aged under 18 years, * pre-treated by at least one protease inhibitor (pi) line, * in therapeutic failure of the antiretroviral (arv) maintenance treatment containing kaletra®. therapeutic failure is defined by a viral load\> 50 copies/ml after at least three months' treatment with an arv combination containing kaletra®, always provided that genotyping is possible . exclusion criteria: * patients having received less than three months of kaletra®, * patients for whom the genotype information before starting kaletra® and at the time of the failure of kaletra® was not available, * patients receiving another protease inhibitor (pi) concomitantly with kaletra®.

Keywords: evaluation of the impact of kaletra on antiretroviral resistance
public health initiative on alcohol flushing

Conditions: Alcohol Toxicity

Summary: the overall aim of the study is to raise awareness of alcohol flushing and its health risks to the general population. the primary objective is to see if spreading awareness of the health risks of alcohol flushing and understanding personalized genotype information will lead to changes in alcohol consumption behavior.


Eligibility criteria:
inclusion criteria: * adult age over 18 * native english speaker exclusion criteria: * none

Keywords: alcohol flushing
tdap and biomarkers of alzheimer's disease

Conditions: Alzheimer Disease, Late Onset

Summary: recently, the tdap (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis) vaccination was added to the list of immunizations associated with lower incidence of dementia. plasma-based biomarkers for ad are a welcome alternative to expensive and invasive testing for alzheimer's; these biomarkers include assessment of amyloid and tau and neurofilament light protein that assesses non-specific neurodegeneration. the investigators will test for these biomarkers, as well as some immune parameters, administer tdap then repeat the blood tests in six months.

a growing number of studies have consistently shown reduced incident risk of dementia associated with a variety of vaccinations. most recently, data probes of medical claims from two large and disparate databases showed that vaccination for tetanus, diphtheria and pertussis (tdap) was associated with a 42% decrease in dementia. adult vaccination coverage remains low for most routinely recommended vaccines, including tdap. this study will screen and qualify participants who do not meet the recommended frequency interval for tdap vaccination. participants will have consented to a review of their medical history (including vaccination history), a neurocognitive test and a battery of blood tests. included in the blood testing will be plasma-based testing for amyloid, tau and neurofilament light protein. the study will be considered a pilot study; it will be an open-label trial. all participants will receive a single dose of the tdap vaccine. nine months after vaccination, participants will repeat the pre-vaccine blood tests. primary objective will be the assessment of change in the alzheimer's disease (ad) biomarkers. bordetella pertussis (b. pertussis), the bacterium that causes whopping cough, is one of the targets of the tdap vaccine. b. pertussis is a hypothesized infectious trigger of alzheimer's disease (ad). a secondary objective of the study will be determination of present and past infection by b. pertussis via igg testing as well as pcr of nasal swab and how this may relate to the alzheimer biomarker responses to tdap vaccination.

Eligibility criteria:
inclusion criteria: * immuno- competent * out of compliance for tdap vaccine (none within 10 years). * ability of give informed consent. * sage test 17 or greater exclusion criteria: * immuno- compromised * in compliance for tdap vaccination (within 10 years). * known allergy to components of the tdap vaccine. * sage test \<17

Keywords: tdap alzheimer's biomarkers b. pertussis immune risk profile
a study of 25-hydroxy vitamin d levels in non-itching hemodialysis patients

Conditions: Vitamin D Deficiency; End Stage Renal Disease

Summary: hypothesis: 25-hydroxy vitamin d levels in non-itching hemodialysis (hd) patients will be higher than those in hd patients with itching 25-hydroxy vitamin d levels will be measured in non-itching hemodialysis patients and compared to levels previously measured in a previous study of 25-hydroxy vitamin d levels of patients complaining of itching.

25-hydroxy vitamin d levels from non-itching hd patients in this study will be compared to 25-hydroxy vitamin d levels from our ongoing study in hd patients with itching. the primary endpoints for both studies are continuous variables. student's t test will be used to test for statistical significance. multiple regression analysis will be used for controlling covariates and testing the interaction among covariates.

Eligibility criteria:
inclusion criteria: * hemodialysis treatment for \> 3 months no complaints of itching within 1 month prior to study enrollment exclusion criteria: * age \< 18 years * failure to provide informed consent * intact pth \ 1,000 pg/ml * serum phosphorus \> 7.0 * serum calcium (adjusted for albumin)\> 11 * active malignancy * likelihood of imminent renal transplantation * current ergocalciferol treatment

Keywords: pruritis in hemodialysis patients 25-vitamin d in chronic kidney disease
child (child health and infection with low density) malaria

Conditions: Malaria,Falciparum; Malaria

Summary: this trial will assess the long-term health and socioeconomic impact of interventions targeting low-density malaria infection (lmi) among children in tanzania

this is a 3-arm open-label randomized control trial of 600 children aged 6 months to 10 years in tanzania, where transmission is low and a high proportion of infections are low-density. standard of care based on passive case detection (pcd) using rapid diagnostic test (control arm) will be compared to two different approaches to detect and treat p. falciparum lmi: active case detection using molecular testing (acdm) and pcd using molecular testing (pcdm). aims are: 1. to assess the impact of standard pcd plus acdm vs standard pcd on long-term child health 2. to assess the impact of pcdm vs standard pcd on long-term child health 3. to evaluate the cost-effectiveness of acdm and pcdm

Eligibility criteria:
inclusion criteria: 1. 6 months to 10 years of age of age at enrollment 2. primary residence in the study area during the study period 3. agree to come to study clinic for any illness 4. agree to avoid medications outside the study, even herbal medication exclusion criteria: 1. another child from household already randomly selected for recruitment 2. not able or does not provide informed consent 3. need for emergency intervention 4. known history of chronic illness requiring regular specialty care including diabetes mellitus, cancer, or stage 3 or 4 hiv/aids 5. contraindications to artemether-lumefantrine (al) including history of allergic reaction, weight under 5 kg 6. participation in another active/ongoing intervention trial

Keywords: malaria child health chronic infection subclinical infection patent infection subpatent infection active case detection passive case detection fever case management
visualization of inspiratory effort and respiratory mechanics to promote lung- and diaphragm protective ventilation

Conditions: Respiratory Muscles; Respiration, Artificial; Respiratory Function Tests

Summary: this is a multicentre prospective cohort trial in adult and pediatric icu patients. the investigators will measure the effect of a patient's inspiratory effort during mechanical ventilation on the lungs and diaphragm. the investigators will daily (for a maximum of 8 days) measure esophageal pressures with a balloon catheter to quantify inspiratory effort and respiratory muscle function, and perform daily ultrasound measurements of the diaphragm and the lungs. the investigators hypothesize that a small inspiratory effort will result in the preservation of diaphragm function and have no adverse effect on lung function.


Eligibility criteria:
inclusion criteria: * age \> 28 days * weight \> 3kg * requiring invasive mechanical ventilation * anticipated length of ventilation \> 48h exclusion criteria: * refusal of consent * mechanical ventilation ≤ 2 weeks before inclusion * known anatomical malformation of the diaphragm (including congenital diaphragmatic hernia) * contra-indication to the placement of a naso-gastric esophageal balloon catheter
enhanced recovery after surgery (eras) in live donor kidney transplant recipients

Conditions: Postoperative Pain

Summary: the goal of this interventional study is to learn if an enhanced recovery after surgery (eras) protocol works to reduce the need for narcotic pain medications in live donor kidney transplant recipients. the main questions it aims to answer are: does the eras protocol lower the amount of opioid narcotic medication needed to manage post-surgery pain? does the eras protocol help lower pain scores after surgery? researchers will compare the eras protocol to previous patients where the eras protocol was not used to see if the eras protocol works to reduce post-surgery pain. participants will be asked to: * drink a pre-surgery carbohydrate drink two hours before your surgery. * take a pre-surgery dose of tylenol by mouth. * take a pre-surgery dose of gabapentin by mouth. * the surgeon will administer a local numbing medication at the surgery site by injection during the surgery. * begin walking with assistance about 12 hours after your surgery. * allow the research staff to collect data about your kidney function. this data will be collected on your postoperative clinic visits, which generally occur about twice weekly for one month. this information will determine your kidney health, need for hospitalization, and side effects that may occur.


Eligibility criteria:
inclusion criteria: * adult patients, over 18 years of age, receiving a kidney transplant from a living donor. exclusion criteria: * delayed gastric emptying, severe type i diabetes, allergy to interventional medications, pregnancy (this is a normal exclusion for kidney recipients)

Keywords: transplantation, kidney renal transplantation enhanced postsurgical recovery recovery, enhanced postsurgical pain, postoperative postsurgical pain